The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Sino-Nasal Outcome Test (SNOT-22)
研究概览
简要总结
Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden. Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely contributor to recalcitrant disease. Emerging evidence shows that colloidal silver nanoparticles may be effective for reducing biofilms. The investigators intend to perform a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness and safety of intranasal colloidal silver nanoparticles in adult patients with chronic rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement in symptom scores and will not be associated with increased rate of adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS):
- •mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion), facial pain-pressure-fullness, or decreased sense of smell
- •AND inflammation is documented by one or more of the following findings:
- •purulent (not clear) mucus or edema in the middle meatus or ethmoid region
- •polyps in nasal cavity or the middle meatus
- •and/or radiographic imaging showing inflammation of the paranasal sinuses
排除标准
- •Unable to speak English
- •History of nasal or sinus surgery within past 6 weeks
- •History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
- •Dependence on prolonged corticosteroid therapy for comorbid condition
- •History of renal impairment
- •History of cerebrospinal fluid leak
研究组 & 干预措施
Colloidal Silver
The colloidal silver arm will administer intranasal colloidal silver, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day (8 mcg of silver per day), for 28 days.
干预措施: Colloidal silver nanoparticles (Drug)
Purified Water
The placebo arm will administer intranasal purified water, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day, for 28 days.
干预措施: Purified Water (Other)
结局指标
主要结局
Sino-Nasal Outcome Test (SNOT-22)
时间窗: Four weeks
Assess change in SNOT-22 score
次要结局
未报告次要终点